BETAMETHASONE DIPROPIONATE GEL, 0.05%
(AUGMENTED*)
(Potency expressed as betamethasone)

* Vehicle augments the penetration of the steroid.

FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC USE

Rx only

Betamethasone dipropionate gel (augmented) contains betamethasone dipropionate, USP, a syn-thetic fluorinated corticosteroid for topical dermatologic use. Betamethasone dipropionate is included in a class of compounds consisting primarily of synthetic corticosteroids for use topically as anti-inflammatory and anti-pruritic agents.

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C₂₈H₃₇FO₇, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of betamethasone dipropionate gel (augmented) contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented gel base of purified water, propylene glycol, carbomer 940, and sodium hydroxide.

Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, anti-pruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of their common pre-cursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.

Betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

This product is not recommended for use in pediatric patients under 12 years of age.

Betamethasone dipropionate gel (augmented) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

In controlled clinical trials, the total incidence of adverse events associated with the use of betamethasone dipropionate gel (augmented) was 10%. These included stinging or burning in 6% of patients, dry skin in 4% of patients, and pruritus in 2% of patients. Less frequently reported adverse reactions were irritation, skin atro- phy, telangiectasia, erythema, cracking/tightening of the skin, follicular rash, and allergic contact dermatitis.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids, such as betamethasone dipropionate gel (augmented).

These reactions are uled in approximate decreasing order of occurrence: acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae and miliaria.

Topically applied betamethasone dipropionate gel (augmented) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Apply a thin layer of betamethasone dipropionate gel (augmented) to the affected skin once or twice daily and rub it in gently and completely.

Betamethasone dipropionate gel (augmented) is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g per week should not be used.

Betamethasone dipropionate gel (augmented) should not be used with occlusive dressings.

Betamethasone Dipropionate Gel, 0.05% (augmented) is supplied as follows:

Store between 2° and 25°C (36° and 77°F).

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I2266A
R5/03
#194